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Search / Trial NCT05517928

A Study to Evaluate the Impact of Lactobacillus Rhamnosus GG on Proton Pump Inhibitor-Induced Gut Dysbiosis

Launched by MAYO CLINIC · Aug 24, 2022

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how a specific probiotic called Lactobacillus rhamnosus GG (often referred to as LGG) can help with changes in gut bacteria caused by proton pump inhibitors (PPIs). PPIs are medicines that lower stomach acid and are commonly used to treat issues like acid reflux. The study aims to see if taking LGG can improve the balance of helpful bacteria in the gut for people who are taking these medications.

To participate in this study, you need to be healthy and between the ages of 65 and 74, and you should not have any ongoing gastrointestinal symptoms. This means you should not be on any special diets or have any major health issues that affect your gut. If you join the study, you'll be part of a group that is helping researchers understand how probiotics may support gut health while taking PPIs. It's important to note that certain conditions, like recent surgeries affecting the gut or pregnancy, will prevent someone from participating. This trial is currently recruiting participants, so if you meet the criteria and are interested, you could help contribute to important health research!

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Individuals on an unrestricted regular diet with no dietary restrictions (vegan, low FODMAP, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.).
  • Healthy subjects will be screened for current or chronic GI symptoms using a 16-item questionnaire.
  • Only those with an absence of symptoms will eligible to participate.
  • Exclusion Criteria:
  • For healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy).
  • Chronic daily use of medications affecting GI secretion or motor function.
  • The presence of any GI-motility affecting systemic diseases or untreated psychiatric disease.
  • Pregnancy.

About Mayo Clinic

Mayo Clinic is a renowned nonprofit medical practice and research institution dedicated to providing comprehensive healthcare and advancing medical knowledge through innovative research and education. With a commitment to patient-centered care, Mayo Clinic conducts numerous clinical trials aimed at exploring new therapies and improving treatment outcomes across various disciplines. Leveraging a multidisciplinary approach, the institution collaborates with leading experts and cutting-edge technology to ensure rigorous scientific standards and ethical practices in all its research endeavors. Through its trials, Mayo Clinic seeks to translate breakthroughs in science into tangible benefits for patients, fostering advancements in medicine that enhance health and quality of life.

Locations

Scottsdale, Arizona, United States

Patients applied

0 patients applied

Trial Officials

John DiBaise, MD

Principal Investigator

Mayo Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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